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Recruiting

NCT Number: NCT07135505

Early Time-Restricted Eating in Older Adults With Hypertension

The purpose of this study is to find out how early time-restricted eating affects body rhythms and improves cardiometabolic health in older adults.

Recruiting

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location status: Recruiting

Location contact

Yi Lin, PhD

CONTACT

[email protected]

205-996-5876

Yi Lin, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Consent to participate in the study
  • Men and women ≥ 60 years old
  • Average office systolic BP ≥130 mmHg
  • Self-reported ≥12 hours eating period per day of at least 5 days/week
  • Stable health history over the past 2 months

Exclusion criteria

  • Fasting >12 hours per day
  • Actively trying to lose weight by participating in formal weight loss program or significantly restricting calorie intake
  • Have lost ≥ 10 pounds in last 3 months
  • Unable to wake up at a regular time between 6-8 am
  • Perform overnight shift work more than 1day/week on average
  • Resting heart rate of >120 beats per minute, systolic blood pressure > 180 mmHg and/or diastolic blood pressure of > 100 mmHg
  • Have been diagnosed with diabetes
  • On insulin or diabetes medication
  • Unstable angina, heart attack or stroke in the past 3 months
  • Continuous use of supplemental oxygen to manage a chronic pulmonary condition or heart failure
  • Pregnant or breastfeeding
  • Rheumatoid arthritis, Parkinson's disease or currently on dialysis
  • Current diagnosis of a major psychiatric condition that would impair study participation
  • Severe gastrointestinal disease, major gastrointestinal surgery, or active gallstone disease
  • Active treatment for cancer in the past year
  • Taking medications that preclude fasting for 16 hours (e.g. must be taken with food at least 12 hours apart)

Treatment and study plan

Early time-restricted eating

Behavioral

The participants will be asked to fast for a target of 16 hours per day (eat ad libitum within the 8-hour eating window, starting between 6:30-8:30 am), 6 days/week for 12 weeks. Participants will be allowed to consume calorie-free beverages, sugar-free gum, and will be encouraged to drink plenty of water throughout the entire intervention period.

Primary outcomes

  1. Blood glucose

    Time frame: Baseline and 12 weeks

    measured by the continuous glucose monitor

  2. Heart rate variability

    Time frame: Baseline and 12 weeks

    measured by the Holter monitor

  3. Systolic Blood pressure

    Time frame: Baseline and 12 weeks

    measured by the ambulatory blood pressure monitor

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • UAB Nutrition Obesity Research Center

Registry information

Official study title

The Effect of Early Time-Restricted Eating on Cardiometabolic Health and Circadian Rhythms in Hypertensive Older Adults With Habitual Prolonged Eating Window

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 22, 2025
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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